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SAMPLE October 2007 GP41-A6 Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved
SAMPLE October 2007 GP41-A6 Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved

October 2007

GP41-A6

Procedures for the Collection of Diagnostic

Blood Specimens by Venipuncture; Approved

Standard—Sixth Edition

Specimens by Venipuncture; Approved Standard—Sixth Edition This document provides procedures for the collection of
Specimens by Venipuncture; Approved Standard—Sixth Edition This document provides procedures for the collection of
Specimens by Venipuncture; Approved Standard—Sixth Edition This document provides procedures for the collection of
Specimens by Venipuncture; Approved Standard—Sixth Edition This document provides procedures for the collection of
Specimens by Venipuncture; Approved Standard—Sixth Edition This document provides procedures for the collection of
Specimens by Venipuncture; Approved Standard—Sixth Edition This document provides procedures for the collection of

This document provides procedures for the collection of diagnostic

specimens by venipuncture, including line draws, blood culture collection, and venipuncture in children.

blood culture collection, and venipuncture in children. A standard for global application developed through the

A standard for global application developed through the Clinical and Laboratory Standards Institute consensus process.

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Clinical and Laboratory Standards Institute

Setting the standard for quality in clinical laboratory testing around the world.

The Clinical and Laboratory Standards Institute (CLSI) is a not-for-profit membership organization that brings together the varied perspectives and expertise of the worldwide laboratory community for the advancement of

a common cause: to foster excellence in laboratory medicine by developing and implementing clinical laboratory

standards and guidelines that help laboratories fulfill their responsibilities with efficiency, effectiveness, and global applicability.

Consensus Process

Consensus—the substantial agreement by materially affected, competent, and interested parties—is core to the

development of all CLSI documents. It does not always connote unanimous agreement, but does mean that the

participants in the development of a consensus document have considered and resolved all relevant objections

and accept the resulting agreement.

Commenting on Documents

CLSI documents undergo periodic evaluation and modification to keep pace with advancements in technologies,

procedures, methods, and protocols affecting the laboratory or health care.

CLSI’s consensus process depends on experts who volunteer to serve as contributing authors and/or as

participants in the reviewing and commenting process. At the end of each comment period, the committee that

developed the document is obligated to review all comments, respond in writing to all substantive comments,

and revise the draft document as appropriate.

Comments on published CLSI documents are equally essential, and may be submitted by anyone, at any time, on

any document. All comments are addressed according to the consensus process by a committee of experts.

Appeals Process

it is believed that an objection has not been adequately addressed, the process for appeals is documented in

If

the CLSI Standards Development Policies and Process document.

All comments and responses submitted on draft and published documents are retained on file at CLSI and are

available upon request.

Get Involved—Volunteer!

Do you use CLSI documents in your workplace? Do you see room for improvement? Would you like to get

involved in the revision process? Or maybe you see a need to develop a new document for an emerging

technology? CLSI wants to hear from you. We are always looking for volunteers. By donating your time and

talents to improve the standards that affect your own work, you will play an active role in improving public health across the globe.

For further information on committee participation or to submit comments, contact CLSI.

Clinical and Laboratory Standards Institute 950 West Valley Road, Suite 2500 Wayne, PA 19087 USA P: 610.688.0100 F: 610.688.0700 www.clsi.org standard@clsi.org

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GP41-A6

ISBN 1-56238-650-6 ISSN 0273-3099

Vol. 27 No. 26 Formerly H03-A6 Vol. 27 No. 26

Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved StandardSixth Edition

Volume 27 Number 26

Dennis J. Ernst, MT(ASCP)

Lisa O. Ballance, BSMT(ASCP)

Roger R. Calam, PhD, DABCC

Ruth McCall, MT(ASCP)

Susan S. Smith

Diane I. Szamosi, MA, MT(ASCP), SH

David J. Warunek, PhD

Abstract

Clinical and Laboratory Standards Institute document GP41-A6Procedures for the Collection of Diagnostic Blood Specimens

by Venipuncture; Approved StandardSixth Edition provides a descriptive, stepwise procedure for the collection of diagnostic

blood specimens by venipuncture. Special considerations for venipuncture in children, line draws, blood culture collection, and

venipuncture in isolation situations are included.

Clinical and Laboratory Standards Institute (CLSI). Procedures for the Collection of Diagnostic Blood Specimens by

Venipuncture; Approved StandardSixth Edition. CLSI document GP41-A6 (ISBN 1-56238-650-6). Clinical and Laboratory

Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087 USA, 2007.

The Clinical and Laboratory Standards Institute consensus process, which is the mechanism for moving a document through

two or more levels of review by the health care community, is an ongoing process. Users should expect revised editions of any

given document. Because rapid changes in technology may affect the procedures, methods, and protocols in a standard or

guideline, users should replace outdated editions with the current editions of CLSI documents. Current editions are listed in

the CLSI catalog and posted on our website at www.clsi.org. If your organization is not a member and would like to become

one, and to request a copy of the catalog, contact us at: Telephone: 610.688.0100; Fax: 610.688.0700; E-Mail:

customerservice@clsi.org; Website: www.clsi.org.

contact us at: Telephone: 610.688.0100; Fax: 610.688.0700; E-Mail: customerservice@clsi.org; Website: www.clsi.org.

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Number 26

GP41-A6

Copyright © 2007 Clinical and Laboratory Standards Institute. Except as stated below, any reproduction of

content from a CLSI copyrighted standard, guideline, companion product, or other material requires express written consent from CLSI. All rights reserved. Interested parties may send permission requests to

CLSI hereby grants permission to each individual member or purchaser to make a single reproduction of

this publication for use in its laboratory procedure manual at a single site. To request permission to use

this publication in any other manner, e-mail permissions@clsi.org.

Suggested Citation

CLSI. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved

StandardSixth Edition. CLSI document GP41-A6. Wayne, PA: Clinical and Laboratory Standards

Institute; 2007.

Proposed Standard

August 1977

Tentative Standard

February 1979

Approved Standard

March 1980

Approved StandardSecond Edition

April 1984

ISBN 1-56238-650-6 ISSN 0273-3099

Approved StandardThird Edition

July 1991

Approved StandardFourth Edition

June 1998

Approved StandardFifth Edition

December 2003

Approved StandardSixth Edition

October 2007

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Volume 27

Contents

Abstract

Committee Membership

Foreword

1

2

3

4

5

6

7

8

Scope

Introduction

Standard Precautions

Definitions

Factors That Affect Laboratory Values

Facilities

6.1

6.2

Supplies

7.1

7.2

7.3

7.4

7.5

7.6

7.7

7.8

7.9

7.10

7.11

7.12

7.13

7.14

Venipuncture Procedure

8.1

8.2 Step 2: Approach and Identify the Patient; Sanitize Hands

8.3 Step 3: Verify Patient Diet Restrictions and Latex Sensitivity

8.4

8.5 Step 5: Position Patient

8.6 Step 6: Apply Tourniquet

8.7 Step 7: Put On Gloves

8.8 Step 8: Cleanse Venipuncture Site

8.9 Step 9: Perform Venipuncture

8.10 Step 10: Order of Draw

Venipuncture Chairs

Hospital Area

Utility Carts

Blood Collecting Trays

Gloves

Needles and Holders

Sterile Syringes

Venous Blood Collection Tubes

Tourniquets

Antiseptics

Gauze Pads

Puncture-Resistant Disposal Container

Ice

Bandages

Warming Devices

Test Reference Manual

Step 1: Prepare Accession Order

Step 4: Assemble Supplies

GP41-A6

i

iii

vii

1

1

1

1

2

2

2

2

3

3

3

3

3

4

4

4

4

4

5

5

5

5

5

5

6

6

8

8

9

10

13

13

14

17

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Contents Continued)

9

10

8.11 Step 11: Release the Tourniquet

8.12 Step 12: Place the Gauze Pad

8.13 Step 13: Remove and Dispose of the Needle

8.14 Step 14: Bandage the Arm

8.15 Step 15: Label Blood Collection Tubes and Record Time of Collection

8.16 Step 16: Observe Special Handling if Required

8.17 Step 17: Send Blood Collection Tubes to the Proper Laboratories

Venipuncture in Children and Difficult Collections

9.1

Equipment

Additional Considerations

9.2

Procedure

11

10.1

10.2

10.3

10.4

Special Situations

11.1

11.2

11.3

Monitoring Blood Volume Collected

Hematoma

Hemolysis

Nerve Damage

Timed Intervals

Specific Collection Techniques

Indwelling Lines, Heparin or Saline Locks, Vascular Access Devices

(VADs)

11.4

11.5

11.6

11.7

Fistula

IV Fluids

Isolation

Emergency Situations

References

Summary of Consensus Comments and Subcommittee Responses

Summary of Delegate Comments and Subcommittee Responses

The Quality Management System Approach

Related CLSI Reference Materials

GP41-A6

18

18

18

18

18

19

19

20

20

20

20

20

20

20

21

21

21

21

22

22

23

24

25

27

30

36

40

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Volume 27

GP41-A6

Foreword

The errors that can occur during the collection and handling of blood specimens are potentially numerous, and the complications to the patient potentially harmful. Standards for venipuncture can reduce or alleviate many of these errors in much the same way that quality control standards have reduced errors within the laboratory.

Without fully implementing global standards, it is less likely that biologically representative specimens

will be obtained from patients and that their results will be comparable from one institution to another. A comprehensive training program is needed to produce efficient, well-trained phlebotomists who collect

specimens that accurately reflect the patients’ physiology.

Various comments received on the previous edition of this standard were reviewed and incorporated

where appropriate. All comments and the subcommittee’s responses are summarized at the end of the

document.

This document replaces the fifth edition approved standard, H3-A5, which was published in 2003. Several

changes were made in this edition; chief among them are new illustrations of the anatomy of the

antecubital area, instructions on recognizing nerve involvement, revised instructions for drawing blood

from patients with vascular access devices, preparing sites for blood culture collections, and an additional

verification step when labeling tubes. References were updated throughout.

Key Words

Accession, blood specimen, phlebotomist, venipuncture

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Volume 27

GP41-A6

Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved StandardSixth Edition

1 Scope

This document establishes criteria for the correct collection of blood specimens by venipuncture. These procedures are intended as a suitable model for adoption by all health care providers responsible for the collection and handling of blood specimens in both outpatient and inpatient settings.

2

Introduction

Since 1977, CLSI has recognized the quality requirement to direct significant attention toward the

preexamination components of laboratory testing, including the correct collection and handling of blood

specimens. Highly sophisticated testing technology cannot produce a good result from a poor specimen.

Proper specimen collection and handling are of the utmost importance because significant errors occur in

the preexamination phase of laboratory testing.

1

Preexamination errors can be numerous (eg, incorrect patient identification, incorrect order of draw,

incorrect use of additive tubes, labeling errors, incorrect timing of collection, clerical errors). Standard

procedures and protocols are intended to prevent these problems and protect against complications and

patient mismanagement that can otherwise arise when specimens are improperly collected.

3

Standard Precautions

Because it is often impossible to know what isolates or specimens might be infectious, all patient and

laboratory specimens are treated as infectious and handled according to “standard precautions.” Standard

precautions are guidelines that combine the major features of “universal precautions and body substance

isolation” practices. Standard precautions cover the transmission of all infectious agents and thus are

more comprehensive than universal precautions, which are intended to apply only to transmission of

blood-borne pathogens. Standard and universal precaution guidelines are available from the US Centers

For specific precautions for preventing the laboratory transmission

for Disease Control and Prevention.

of all infectious agents from laboratory instruments and materials and for recommendations for the

management of exposure to all infectious disease, see CLSI document M29.

2

3

4

Definitions

In the context of this publication, the terms listed below are defined as follows:

accession the steps required to ensure that a specific patient specimen and the accompanying

documentation are unmistakably identified as referring to the same patient.

angle of insertion the angle formed by the surface of the arm and the needle entering the arm.

preevacuation the creation of a vacuum (in a collection tube), induced by either the manufacturer or by the user immediately before a liquid specimen is taken.

specimen (patient) the discrete portion of a body fluid or tissue taken for examination, study, or analysis of one or more quantities or characteristics to determine the character of the whole.

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GP41-A6

vascular access device (VAD) a device inserted temporarily or permanently into a vein and/or artery to allow access to the circulatory system for the administration of fluids or medications, or for various procedures; NOTE: Examples include central venous lines for hyperalimentation or chemotherapy, and arteriovenous shunts for hemodialysis.

venipuncture the puncture of a vein for surgical or therapeutic purposes, or for collecting blood specimens for analysis.

5 Factors That Affect Laboratory Values

Interpretation of laboratory data has assumed new importance and attracted increased attention with both

more frequent testing and multiple testing. Even when an analytical procedure is performed correctly and

precisely, variables can affect the test result. Knowledge of these variables and standardization of

laboratory testing procedures are essential for correct interpretation and optimal use of the data.

Major causes of “laboratory error” can be related to nonanalytical factors, such as specimen collection,

handling, and transport. Nonbiological factors, such as patient misidentification, and biological factors,

such as patient posture and the time a specimen is drawn, all contribute to the total “laboratory error.”

Physiological factors that influence results include age, activity, bed rest, food ingestion, alcohol

ingestion, menstrual cycle, obesity, oral contraceptives, posture, pregnancy, race, sex, smoking, and time

day. Many biological phenomena exhibit rhythms, with the circadian rhythm (the change in a 24-hour

of

period) being the most important to laboratory testing. Many factors with documented effects on

laboratory values are published.

4,5

6

If

rooms for pediatric patients should be considered.

Facilities

possible, perform the venipuncture in a clean, quiet, and private environment. Reasonably soundproof

The room should have facilities to allow the phlebotomist to wash his/her hands between patients.

Washing with soap and running water is recommended; however, any standard detergent product

acceptable to personnel may be used. In settings where water is not available, alcohol-based gels or

liquids, hand-wipe towelettes, and cleansing foams can be used.

6.1

Venipuncture Chairs

Venipuncture chairs should be designed for the maximum comfort and safety of the patient.

Consideration should be given to the ergonomic comfort plus easy accessibility to the patient for the

phlebotomist. Both armrests of the chairs should be adjustable so the best venipuncture position for each

patient can be achieved. The chair should have a safety feature (eg, arm rests) to prevent patients from

falling if feeling faint. There is no requirement for specialized commercially available “phlebotomy chairs.”

6.2 Hospital Area

A central phlebotomy area should be designed to include the following features.

6.2.1 Central Desk

The central desk is a location for a telephone system used to handle emergency request calls, facilities for processing daily and future requests, and a paging system for contacting the phlebotomist who is collecting specimens outside the central area.

2

© Clinical and Laboratory Standards Institute. All rights reserved.

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Number 26

GP41-A6

The Quality Management System Approach

Clinical and Laboratory Standards Institute (CLSI) subscribes to a quality management system approach in the development of standards and guidelines, which facilitates project management; defines a document structure via a template; and provides a process to identify needed documents. The approach is based on the model presented in the most current edition of CLSI/NCCLS document HS1A Quality Management System Model for Health Care. The quality management system approach applies a core set of “quality system essentials” (QSEs), basic to any organization, to all operations in any health care service’s path of workflow (ie, operational aspects that define how a particular product or service is provided). The QSEs provide the framework for delivery of any type of product or service, serving as a manager’s guide. The QSEs are:

Documents & Records

Organization

Personnel

Equipment

Purchasing & Inventory

Process Control

Information Management

Occurrence Management

Assessments―External &

Internal

Process Improvement

Customer Service

Facilities & Safety

GP41-A6 addresses the QSEs indicated by an “X.” For a description of the other documents listed in the grid, please

refer to the Related CLSI Reference Materials section on the next page.

Documents

& Records

Organization

Personnel

Equipment

Purchasing &

Inventory

Process

Control

Information

Management

Occurrence

Management

Assessments

External &

Internal

Process

Improvement

Customer Service

Facilities &

Safety

H11

 

H11

H11

 

X

 

X

H1

   

H11

   

X

H1

H1

H11

H4

T/DM6

M29

H11

H18

H21

Adapted from CLSI/NCCLS document HS1A Quality System Model for Health Care.

Path of Workflow

A path of workflow is the description of the necessary steps to deliver the particular product or service that the

organization or entity provides. For example, CLSI/NCCLS document GP26Application of a Quality

Management System Model for Laboratory Services defines a clinical laboratory path of workflow which consists of

three sequential processes: preexamination, examination, and postexamination. All clinical laboratories follow these

processes to deliver the laboratory’s services, namely quality laboratory information.

GP41-A6 addresses the clinical laboratory path of workflow steps indicated by an “X.” For a description of the other

documents listed in the grid, please refer to the Related CLSI Reference Materials section on the next page.

 

Preexamination

   

Examination

Postexamination

Examination

ordering

Sample

collection

Sample

transport

Sample

receipt/

processing

Examination

Results

review and

follow-up

Interpretation

Results

reporting and

archiving

Sample

management

 

X

 

X

 

X

 

X

X

 

X

     

H11

H1

C38

C38

H18

T/DM6

 

H11

H4

H4

H21

H11

H11

 

H18

 

H21

Adapted from CLSI/NCCLS document HS1A Quality System Model for Health Care.

40

© Clinical and Laboratory Standards Institute. All rights reserved.

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Volume 27

Related CLSI Reference Materials *

GP41-A6

C38-A

Control of Preanalytical Variation in Trace Element Determinations; Approved Guideline (1997). This document provides guidelines for patient preparation, specimen collection, transport, and processing for the measurement of trace elements in a variety of biological matrices.

H1-A5

Tubes and Additives for Venous Blood Specimen Collection; Approved StandardFifth Edition (2003). This document contains requirements for venous blood collection tubes and additives, including technical descriptions of ethylenediaminetetraacetic acid (EDTA), sodium citrate, and heparin compounds used in blood collection devices.

H4-A5

Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens; Approved Standard

Fifth Edition (2004). This document provides a technique for the collection of diagnostic capillary blood

specimens, including recommendations for collection sites and specimen handling and identification.

Specifications for disposable devices used to collect, process, and transfer diagnostic capillary blood specimens

are also included.

H11-A4 Procedures for the Collection of Arterial Blood Specimens; Approved StandardFourth Edition (2004).

This document provides principles for collecting, handling, and transporting arterial blood specimens to assist with

reducing collection hazards and ensuring the integrity of the arterial specimen.

H18-A3

Procedures for the Handling and Processing of Blood Specimens; Approved GuidelineThird Edition

This document includes criteria for preparing an optimal serum or plasma sample and for the devices used

to process blood specimens.

(2004).

H21-A4 Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays;

Approved GuidelineFourth Edition (2003). This document provides procedures for collecting, transporting,

and storing blood; processing blood specimens; storage of plasma for coagulation testing; and general

recommendations for performing the tests.

M29-A3 Protection of Laboratory Workers From Occupationally Acquired Infections; Approved GuidelineThird

Edition (2005). Based on U.S. regulations, this document provides guidance on the risk of transmission of

infectious agents by aerosols, droplets, blood, and body substances in a laboratory setting; specific precautions for

preventing the laboratory transmission of microbial infection from laboratory instruments and materials; and

recommendations for the management of exposure to infectious agents.

T/DM6-A

Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline (1997). This guideline provides

technical and administrative guidance on laboratory procedures related to blood alcohol testing, including

specimen collection, methods of analysis, quality assurance, and reporting of results.

* Proposed-level documents are being advanced through the Clinical and Laboratory Standards Institute consensus process; therefore, readers should refer to the most current edition.

© Clinical and Laboratory Standards Institute. All rights reserved.

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ISBN 1-56238-650-6

610.688.0100 E: customerservice@clsi.org Toll Free (US): 877.447.1888 www.clsi.org F: 610.688.0700 ISBN 1-56238-650-6
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